Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

NCT05549843 | Completed

• 1 other identifier: He-AnklePilot
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy. Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain. Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. The treatment program includes 10 exercises that must be administered bilaterally. Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment. Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.

Conditions

Hemophilia

Outcome Measures

Primary Outcomes (1)

• Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks

  Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.

  Screening visit, within the first seven days after treatment and after two months follow-up

Secondary Outcomes (4)

• Change from baseline ankle joint pain after treatment and at 3 weeks

  Screening visit, within the first seven days after treatment and after two months follow-up

• Change from baseline pressure pain threshold of ankle after treatment and at 3 weeks

  Screening visit, within the first seven days after treatment and after two months follow-up

• Change from baseline ankle joint damage after treatment and at 3 weeks

  Screening visit, within the first seven days after treatment and after two months follow-up

• Change from baseline ankle range of motion after treatment and at 3 weeks

  Screening visit, within the first seven days after treatment and after two months follow-up

Study Arms (1)

Hemophilia group

EXPERIMENTAL

Intervention protocol: * Preparatory work: active mobilizations with the patient supine. * Global passive mobilization of the forefoot and midfoot. * Calcaneocuboid mobilization, functional and structural work of said joint. * Astragaloscaphoid mobilization, functional and structural work of said joint. * Talar manipulation dorsally. * Manipulation-tibial displacement: * Tibiotarsal decompression: 2 very gentle high-speed and short-course tibial-tarsal manipulations. * Plantar fascia induction for foot captors of the plantar fascia. * Tibiotarsal sustained traction technique (unwinding) * Sural triceps induction technique:

Other: Manual therapy

Interventions

Manual therapy OTHER

Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week over a period of 3 weeks. Each session is made up of 10 steps, of which 9 correspond to manual interventions commonly used in the field of manual therapy.

Hemophilia group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with hemophilia A and B
• With severe (\<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
• Over 18 years
• With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
• In prophylactic treatment with FVIII / FIX concentrates for coagulation

You may not qualify if:

• Patients with inhibitors (antibodies against FVIII or FIX)
• Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
• Failure to sign the informed consent document

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

Related Publications (1)

• Truque-Diaz C, Merono-Gallut J, Cuesta-Barriuso R, Perez-Llanes R. Joint and Myofascial Manual Therapy Techniques in Haemophilic Ankle Arthropathy: A Randomized Pilot Study. Haemophilia. 2025 Mar;31(2):295-303. doi: 10.1111/hae.70002. Epub 2025 Feb 7.

  PMID: 39917949 DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 14, 2022
• Primary Completion: November 18, 2022
• Study Completion: February 26, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)